Neuropathic Pain Clinical Trial
Official title:
The Effect of Lacosamide in Peripheral Neuropathic Pain: a Randomized, Double-blind, Placebo Controlled, Phenotype-stratified Study
Verified date | February 2023 |
Source | Danish Pain Research Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The main purpose of this study is to compare the change in pain intensity during treatment with a sodium-channel blocker (lacosamide) in patients with peripheral neuropathic pain with and without the irritable nociceptor phenotype.
Status | Terminated |
Enrollment | 63 |
Est. completion date | June 3, 2022 |
Est. primary completion date | June 3, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Age = 18 years. 2. Probable or definite peripheral neuropathic pain for at least 3 months (Finnerup et al. 2016) 3. Average pain intensity of at least 4 and not above 9 on a 0-10 NRS during the 7-day baseline week (Dworkin et al. 2012). 4. Written informed consent. Exclusion Criteria: 1. Other causes of pain in the same area, or other concomitant pain that cannot be distinguished from the neuropathic pain 2. Patient who cannot cooperate or are unable to complete the project and patients who do not speak Danish. 3. Known and current cardiac conduction disturbance (2° or 3° atrioventricular (AV) block, prolonged QTc interval > 450 ms, heart rate <50 or >110 bpm, a QRS interval >120ms (ECG required)), significant cardiac, renal or liver disease or other severe illness. In patients treated with pregabalin also PQ interval > 0,2s and cardiac disease. Sitting diastolic blood pressure below 50 mmHg or above 105 mmHg. 4. Major depressive episode within 6 months, recurrent depressive disorder or other significant psychiatric disease, alcohol, illicit drug or drug abuse. 5. Pregnancy or lactation 6. Woman of childbearing potential, unless they use and acceptable effective contraception measure as defined in the Clinical Trials Facilitation Group (CTFG) during the study and at least 2 weeks after, or if their male partner is vasectomized and their sole partners. Negative pregnancy test is required. 7. Known allergy to lacosamide or excipients. 8. Concomitant pain treatment with tricyclic antidepressants, topical analgesics (lidocaine, capsaicin), lamotrigine, oxcarbazepine, cannabinoids or strong opioids that cannot be discontinued. Other treatment for neuropathic pain are allowed in a stable dose (from 14 days before randomization to completion of the trial), if they cannot be tapered off completely. 9. Concomitant treatment with products known to be associated with PQ (PR) prolongation other than pregabalin. 10. Patients inappropriate for placebo 11. Planned surgery 12. Use of sodium channel blockers within at least five half-lives and investigational drugs within 30 days. 13. Patients on controlled sodium diet, unless the amount of sodium in the capsules is acceptable for their diet. 14. The score "yes" on item 4 or item 5 of the Suicidal Ideation section of the Columbia Suicide Severity Rating Scale (C-SSRS), if the ideation occurred in the past 6 months, or "yes on any item of the Suicidal Behaviour section, except for the "Non-suicidal Self Injurious Behaviour" if this behaviour occurred in the past 2 years. |
Country | Name | City | State |
---|---|---|---|
Denmark | Danish Pain Research Center, Aarhus University Hospital | Aarhus |
Lead Sponsor | Collaborator |
---|---|
Danish Pain Research Center | Odense University Hospital |
Denmark,
Dworkin RH, Turk DC, Peirce-Sandner S, Burke LB, Farrar JT, Gilron I, Jensen MP, Katz NP, Raja SN, Rappaport BA, Rowbotham MC, Backonja MM, Baron R, Bellamy N, Bhagwagar Z, Costello A, Cowan P, Fang WC, Hertz S, Jay GW, Junor R, Kerns RD, Kerwin R, Kopecky EA, Lissin D, Malamut R, Markman JD, McDermott MP, Munera C, Porter L, Rauschkolb C, Rice ASC, Sampaio C, Skljarevski V, Sommerville K, Stacey BR, Steigerwald I, Tobias J, Trentacosti AM, Wasan AD, Wells GA, Williams J, Witter J, Ziegler D. Considerations for improving assay sensitivity in chronic pain clinical trials: IMMPACT recommendations. Pain. 2012 Jun;153(6):1148-1158. doi: 10.1016/j.pain.2012.03.003. Epub 2012 Apr 9. — View Citation
Finnerup NB, Haroutounian S, Kamerman P, Baron R, Bennett DLH, Bouhassira D, Cruccu G, Freeman R, Hansson P, Nurmikko T, Raja SN, Rice ASC, Serra J, Smith BH, Treede RD, Jensen TS. Neuropathic pain: an updated grading system for research and clinical practice. Pain. 2016 Aug;157(8):1599-1606. doi: 10.1097/j.pain.0000000000000492. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pain intensity | The difference in the mean value of the patient's daily ratings of average pain intensity in the baseline week and the last week during treatment as experienced during the past 24 hours rated on a 0-10 point numeric rating scale (NRS; 0 = no pain, 10 = worst possible pain).
The primary objective is to compare the change in pain intensity from baseline to last week of lacosamide treatment in patients with and without the irritable nociceptor phenotype in the PP population. The supportive objective is to compare the effect of lacosamide vs. placebo in the two phenotype groups in the PP population. Although we do not expect a phenotype difference in the response to placebo, a comparison of the effect of lacosamide vs. placebo is needed to justify that the phenotype is a predictive biomarker for the effect of lacosamide. |
12 weeks | |
Secondary | Pain relief | (complete, good, moderate, mild, none, worse pain) . Measured at last visit/end of treatment period. | 12 weeks | |
Secondary | Use of escape medicine (paracetamol) during treatment period. | Number of paracetamol tablets during the 12 weeks treatment period. | 12 weeks |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04699734 -
Peripheral Nerve Block in Patients With Painful Diabetic Polyneuropathy
|
N/A | |
Recruiting |
NCT06019325 -
Rhomboid Intercostal Plane Block on Chronic Pain Incidence and Acute Pain Scores After Mastectomy
|
N/A | |
Completed |
NCT05235191 -
Effectiveness and Safety of Methadone Versus Placebo for the Control of Neuropathic Pain in Different Etiologies
|
Phase 3 | |
Completed |
NCT05845177 -
Persistent Pain After Hip Replacement
|
||
Completed |
NCT05496205 -
A SAD Study to Evaluate the Safety, Tolerability and PK/PD of iN1011-N17 in Healthy Volunteers
|
Phase 1 | |
Not yet recruiting |
NCT05949554 -
Electroencephalographic (EEG) Profils for Patients on Intravenous Ketamine.
|
||
Withdrawn |
NCT05052645 -
Ear Acupuncture for Neuropathic Pain
|
N/A | |
Completed |
NCT02824588 -
Working Memory Training for Chronic Neuropathic and Fibromyalgia Pain
|
N/A | |
Completed |
NCT02930551 -
Neuromas as the Cause of Pain
|
N/A | |
Completed |
NCT02866396 -
Impact of Pregabalin in Chronic Users vs. a Perioperative Limited Prescription on Oxycodone Requirement
|
||
Active, not recruiting |
NCT02560545 -
Cannabinoids Effects on the Pain Modulation System
|
N/A | |
Enrolling by invitation |
NCT02485795 -
Observational Study of the Impact of Genetic Testing on Healthcare Decisions and Care in Interventional Pain Management
|
N/A | |
Completed |
NCT02099890 -
The Effect of Diet on Chronic Inflammation and Related Disorders Following Spinal Cord Injury
|
Phase 3 | |
Not yet recruiting |
NCT02246517 -
The Effect of N2O on Chronic Neuropathic Pain Patients
|
Phase 0 | |
Completed |
NCT01946555 -
Prospective Longitudinal Observational Study to Evaluate the Clinical Characteristics and Opioids Treatments in Patients With Breakthrough Cancer Pain
|
N/A | |
Completed |
NCT01718821 -
Assessments on Current Pain Managements in Upper Gastrointestinal Cancer Patients
|
N/A | |
Completed |
NCT01884662 -
Virtual Walking for Neuropathic Pain in Spinal Cord Injury
|
N/A | |
Completed |
NCT01669967 -
The Role of Intravenous (IV) Lidocaine in the Management of Chronic Neuropathic Pain of Peripheral Nerve Origin
|
N/A | |
Completed |
NCT01201317 -
A Study to Investigate the Analgesic Efficacy of AZD2423 Compared With Placebo After 28 Days Treatment in Patients With Painful Diabetic Polyneuropathy
|
Phase 2 | |
Completed |
NCT01207596 -
Evaluating the Efficacy and Safety of Extended Release Hydromorphone (Exalgo) in Patients With Neuropathic Pain
|
Phase 4 |